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M-END

R. A. McNeil Company

M-END DMX


FULL PRESCRIBING INFORMATION: CONTENTS*




FULL PRESCRIBING INFORMATION

Drug Facts

Active ingredients
(in each 5 mL teaspoonful)

Dexbrompheniramine Maleate 0.667 mg
Dextromethorphan HBr 10 mg
Pseudeophedrine HCl 20 mg

Purpose

Antihistamine
Antitussive
Cough Suppressant
Nasal Decongestant

M-END Uses

temporarily relieves these symptoms due to the common cold, hay fever (allergic rhinitis) or other upper respiratory allergies:

  • runny nose
  • sneezing
  • itching of the nose or throat
  • itchy, watery eyes
  • cough due to minor throat and bronchial irritation
  • nasal congestion
  • reduces swelling of nasal passages

Warnings

Do not exceed recommended dosage.

Do not use this product

  • if you are now taking a prescription monoamine oxidase inhibitor (MAOI) (certain drugs for depression, psychiatric, or emotional conditions, or Parkinson's disease), or for 2 weeks after stopping the MAOI drug.  If you do not know if your prescription drug contains an MAOI, ask a doctor or pharmacist before taking this product

Ask a doctor before use if you have

  • a breathing problem such as emphysema or chronic bronchitis
  • glaucoma
  • trouble urinating due to an enlarged prostate gland
  • a cough that lasts or is chronic such as occurs with smoking, asthma or emphysema
  • a cough that occurs with too much phlegm (mucus)
  • heart disease
  • high blood pressure
  • thyroid disease
  • diabetes

Ask a doctor or pharmacist before use if you are taking sedatives or tranquilizers.

When using this product

  • excitability may occur, especially in children
  • may cause marked drowsiness
  • avoid alcoholic drinks
  • alcohol, sedatives, and tranquilizes may increase the drowsiness effect
  • be careful when driving a motor vehicle or operating machinery

Stop use and ask a doctor if

  • cough or nasal congestion persists for more than 1 week, tends to recur, or is accompanied by a fever, rash or persistent headache.  A persistent cough may be a sign of a serious condition.
  • nervousness, dizziness, or sleeplessness occur
  • new symptoms occur

If pregnant or breast-feeding, ask a health professional before use.

Keep out of reach of children.

In case of overdose, get medical help or contact a Poison Control Center right away.

Directions

Do not exceed 4 doses in a 24 hour period.
Adults and children
12 years of age
and over:

3 teaspoonfuls (15 mL)
every 6 hours, not to
exceed 12 teaspoonfuls
in 24 hours
Children 6 to under
12 years of age:



1 1/2 teaspoonfuls
(7.5 mL) every 6 hours,
not to exceed 6
teaspoonfuls in
24 hours
Children under 6
years of age:
Consult a Physician.

M-END Other information

Store at 59°-86°F (15°-30°C)

Inactive ingredients

Bitter Mask, Citric Acid, Glycerin, Propylene Glycol, Purified Water, Sodium Citrate, Sodium Saccharin, Sorbitol, Sucralose, Tutti Frutti Flavor.

Questions? Comments?

Call 1-423-493-9170

Product Packaging

The packaging below represents the labeling currently used.

Principal display panel and side panel for 473 mL label:

NDC 12830-0816-16

M-END DMX

Antihistamine • Antitussive
• Nasal Decongestant

Alcohol Free • Gluten Free
Sugar Free • Dye Free

EACH 5 mL (1 TEASPOONFUL) CONTAINS:
Dexbrompheniramine Maleate.............0.667 mg
Dextromethorphan HBr...........................10 mg
Pseudoephedrine HCl.............................20 mg

Tutti-Frutti Flavor

ONE PINT (473 mL)

Mfg. for R.A. McNeil Company
Chattanooga, TN  37406-3738

Rev. 09/11

Tamper evident by foil seal under cap. Do not
use if foil seal is broken or missing.

THIS BOTTLE IS NOT TO BE DISPENSED TO
THE CONSUMER.


Dispense in a tight, light-resistant container
with a child resistant cap.

Manufactured for:
R.A. McNeil Company
1150 Latta Street
Chattanooga, TN  37406-3738

Rev. 09/11

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M-END

Dexbrompheniramine Maleate, Dextromethorphan Hydrobromide, Pseudoephedrine Hydrochloride LIQUID

Product Information

Product Type Human otc drug label Item Code (Source) NDC:12830-816
Route of Administration ORAL DEA Schedule

Active Ingredient/Active Moiety

Ingredient Name Basis of Strength Strength
Dexbrompheniramine Maleate DEXBROMPHENIRAMINE 0.667 mg
DEXTROMETHORPHAN HYDROBROMIDE DEXTROMETHORPHAN 10 mg
Pseudoephedrine Hydrochloride Pseudoephedrine 20 mg

Inactive Ingredients

Ingredient Name Strength
CITRIC ACID MONOHYDRATE
GLYCERIN
propylene glycol
water
SODIUM CITRATE
saccharin sodium
sorbitol
Sucralose

Packaging

# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:12830-816-16 473 in 1 BOTTLE
2 NDC:12830-816-30 30 in 1 BOTTLE

Marketing Information

Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
part part341 2011-10-13


PLEASE, BE CAREFUL!
Be sure to consult your doctor before taking any medication!
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